Using Fractional Lasers and Tirbanibulin Ointment to Treat Keratinocyte Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.
研究概览
简要总结
The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy confirmed squamous and/or basal cell carcinoma not previously treated by another method.
排除标准
- •Cannot be pregnant at the time of treatment
研究组 & 干预措施
Fractional Laser Only
Treatment of superficial or in situ carcinomas will be with fractional laser only.
干预措施: non-ablative fractional laser (Device)
Fractional Laser and Tirbanibulin Ointment
Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.
干预措施: Tirbanibulin ointment 1% (Drug)
Fractional Laser and Tirbanibulin Ointment
Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.
干预措施: non-ablative fractional laser (Device)
结局指标
主要结局
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.
时间窗: From enrollment to the end of follow-up monitoring at 5 years.
Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.
次要结局
- Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)(Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.)